A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome (ARSGB-ACS)

A Chinese Registry to Determine the Genetics Risk Factors and Serumal Biomarkers for Acute Coronary Syndrome

This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Acute Myocardial Infarction; Unstable Angina

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Luhe Hospital, Capital Medical University
  • Beijing, China, 100029
    • Beijing Anzhen Hospital
  • Dalian, China
    • The Second Hospital of Dalian Medical University
  • Dalian, China
    • The First Affiliated Hospital of Dalian Medical University
  • Jilin, China
    • The First Hospital of Jilin University
  • Zhengzhou, China
    • People's Hospital of Henan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Case-ACS-MACE group consists of patients who was diagnosed as Acute Coronary Syndrome and had a poor prognosis during follow up.

Control-ACS-MACE group consists of patients who was diagnosed as Acute Coronary Syndrome and had a good prognosis during follow up.

Health control group is general population without Acute Coronary Syndrome.

Description

ACS Case Inclusion Criteria:

• Written informed consent has been provided.
• Contact Order Form has been provided.
• Aged 18 years or older.
• Hospitalized within 48 hours of onset of symptoms.

• Diagnosis of STEMI, NSTEMI or UA using the following definitions:

  1.Criteria for STEMI diagnosis:

  1. History of chest pain/discomfort and
  2. Persistent ST-segment elevation (> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission and
  3. Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit.

  2.Criteria for NSTEMI diagnosis:

  1.History of chest pain/discomfort and 2.Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances and 3.Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit. 3.Criteria for Unstable Angina diagnosis:

  1. Symptoms of angina at rest or on minimal exercise and
  2. At least 0.5mm ST deviation in at least 2 leads and
  3. No increase in biomarkers of necrosis

  4. OR objective evidence of ischaemia by non-invasive imaging OR significant coronary stenosis as determined by the treating physician at angiography if this is standard practice in study site.

     Case Exclusion Criteria:

     Patients will not be eligible to participate if any of the following exclusion criteria are present:

• UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
• UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
• Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
• Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
• Current participation in a randomised interventional clinical trial.

Control Inclusion Criteria:

• Age and gender are matched with cases.
• No Coronary Artery Disease was detected by Coronary CT examination.
• Normal biochemical indicators.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
case-ACS-MACE; ACS patients with poor prognosis
control-ACS-MACE; ACS patients with good prognosis
Health-control; general population without ACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample.	The results of metabolomics will be measured by mass spectrometry, including lipids, sugars, amino acids, carnitine, choline, arachidonic acid, sterol and free fat acid . All of metabolites will be quantitative (unit: mol/L). Identification of molecules via Human Metabolites Database will be reported online.	The data is collected from lab in an average of 3 month after the sample recruiting
Detection of miRNAs expression in each participant using the qRT-PCT method.	Relative expression levels of miRNA were analyzed using the 2-△Ct method and U6 was used as an endogenous control.	The data is collected from lab in an average of 3 month after the sample recruiting
Age for each participant	current age and onset age	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Gender for each participant	male or female	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participant	cm cm cm	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participant	kg	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Contact information for each participant	telephone	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Past Medical History	including disease history, surgical history, and medical history	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Lifestyle	including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Biochemical	including blood lipid, fasting glucose, Creatinine and so on	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Biomarkers	including cTnI, BNP, hs-CRP, and so on	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Overall lesion profiles	how many vessels involved	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Echocardiography	LVEF and so on	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Medication at discharge		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Genetic data	Exon sequencing data or genotypes of candidate SNPs	Sequencing will be carried out in an average of 3 months after sample recruiting
Detection of candidate biomarkers in each participant using proteome detection or ELASA		The data is collected from lab in an average of 12 month after the sample recruiting
Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure, recurrent myocardial infarction, stroke or ischemia-driven revascularization.	HF includes in-hospital and long-term post-discharge HF incidence	These data is collected during follow-up visit after discharge

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Investigators: Study Director: Jie Du, PHD, Beijing Anzhen Hospital

Publications and helpful links

General Publications

• Li Y, Chen B, Yang X, Zhang C, Jiao Y, Li P, Liu Y, Li Z, Qiao B, Bond Lau W, Ma XL, Du J. S100a8/a9 Signaling Causes Mitochondrial Dysfunction and Cardiomyocyte Death in Response to Ischemic/Reperfusion Injury. Circulation. 2019 Aug 27;140(9):751-764. doi: 10.1161/CIRCULATIONAHA.118.039262. Epub 2019 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2015
• Primary Completion (Actual): June 1, 2021
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Disease; Coronary Disease; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome; Angina, Unstable
• Other Study ID Numbers: BeijingIHLBVD2018010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No